We are seeking experienced Design Controls and Design History File (DHF) Remediation Specialists to support medical device manufacturers with quality system and product lifecycle compliance initiatives. The successful candidate will serve as a subject matter expert in Design Controls, Risk Management, Design Assurance, and Quality Systems, supporting remediation and reconstruction of Design History Files (DHF), Technical Documentation, and associated records to ensure compliance with FDA, ISO 13485, MDR, and other applicable regulatory requirements. This role requires strong technical writing, regulatory interpretation, project leadership, and cross-functional collaboration skills.
Key Responsibilities
Design Controls & DHF Remediation
Perform assessments of Design History Files (DHF) and Design Control documentation for compliance with FDA, ISO 13485, and company procedures.
Identify documentation gaps and develop remediation plans to address deficiencies.
Create, review, update, and remediate Design Control deliverables, including:
Design and Development Plans
User Needs




Intended Use Statements
Design Inputs
Design Outputs
Design Reviews
Verification Documentation
Validation Documentation
Design Transfer Documentation
Design Change Records
Traceability Matrices
Design History Files (DHF)
Ensure complete traceability between user needs, design inputs, risk controls, verification, validation, and product requirements.
Support legacy product remediation and historical design documentation reconstruction activities.
Quality & Regulatory Compliance
Support Quality Assurance (QA) and Regulatory Affairs (RA) activities for medical device manufacturers.
Ensure compliance with applicable regulations and standards, including:
FDA 21 CFR Part 820 and Design Controls
ISO 13485
ISO 14971 Risk Management
IEC 62304
EU MDR 2017/745
EU MDR and IVDR
Applicable FDA guidance documents
Support remediation programs resulting from audits, inspections, acquisitions, or quality system tra

📌 Remote DHF Remediation Specialist Medical Devices (Ciudad de México)
🏢 Pqe Group
📍 Ciudad de México